Senior Manager, Epidemiology

Jazz Pharmaceuticals; California (MO); Remote; USD 120,000 - 180,000; Full time

Job summary

Jazz Pharmaceuticals seeks a Senior Manager of Epidemiology to lead non-interventional pharmacoepidemiology studies and to support PMR/PMC regulatory commitments across US and EU. You will identify data sources for regulatory submissions and contribute to RMPs, PBRERs and other documents for investigational medicines.

You will develop statistical analysis plans, manage CROs and external investigators, and collaborate with Clinical Development, Medical Affairs, Biostatistics and Regulatory to

Qualifications

• Advanced degree in epidemiology or related field.
• Minimum 2 years in pharma, CRO, or academia.
• Experience with rare disease studies.
• Ability to manage multiple studies and projects.
• Excellent English communication skills.
• Willingness to travel ~10%.

Responsibilities

• Conduct literature searches to identify epidemiology data across geographies.
• Support regulatory submissions (RMPs, safety queries, orphan designations).
• Provide data for forecasting and regulatory deliverables.
• Identify US/EU secondary data sources (claims, EMR).
• Lead RFPs for CROs and data providers for studies.
• Manage external teams to deliver on PMR/PMC timetables.
• Coordinate with Regulatory Leads on submission status.
• Collaborate with Clinical Development, Medical Affairs, Biostatistics.

Skills

Epidemiology

Biostatistics

Regulatory submissions

Project management

Vendor management

Communication skills

Remote work

SAS

R

EMR/claims data

Education

MS/MPH/MSPH/PhD in epidemiology

Tools

SEER*Stat

SAS

R

Job description

Brief Description:

A Senior Manager (SM) of Epidemiology will support the epidemiological activities of Jazz’ Global Research & Development (R&D) organization. This role will be responsible for the scientific leadership and operational management of non-interventional pharmacoepidemiology studies, including studies designed to address Jazz’s post-marketing requirements/commitments (PMR/PMC) to regulatory authorities. This role will also be responsible for identifying relevant epidemiology data for regulatory submissions and documents developed to support clinical development of investigational medicines in Jazz’ R&D portfolio, including Risk Management Plans (RMPs), Periodic Benefit-Risk Reports (PBRERs), orphan designation applications and others. The SM will report to the Senior Director of Epidemiology.

Essential Functions/Responsibilities

• Conduct/outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, and cross-sectional studies describing the demographics, co-morbidities, treatment patterns and concomitant medications of the target patient populations in different geographies
• Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs (e.g., RMPs, safety query responses, orphan drug applications, pediatric waivers, and external control arms) and other processes requiring epidemiological data
• Provide top of the patient funnel data for forecasting/commercial purposes
• Identify appropriate US and EU secondary data sources for studying the target patient populations (e.g., administrative claims and electronic medical records (EMR) databases)
• Lead Requests for Proposal (RFP) and Statement of Work for soliciting proposals and budgets from CROs and Data Providers for outsourced epidemiology studies
• Support a multi-disciplinary non-interventional Phase IV study team to deliver study-related regulatory submissions (e.g., protocols, statistical analysis plans, progress reports, interim study results and final study reports) in accordance with applicable regulatory guidelines and the PMR/PMC timetable set by a Health Authority
• Develop statistical analysis plans in collaboration with the project biostatistician (including those for analyses of administrative claims and EMR databases)
• Manage external investigators, project managers and operational leads at Contract Research Organizations (CROs) and/or Data Providers for outsourced studies to deliver high-quality results on time
• Communicate effectively with the US and EU Regulatory Leads on the timetable and status of all submission deliverables to fulfil a PMR/PMC
• Develop strong partnerships with internal stakeholders (e.g., Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs) to ensure that the appropriate epidemiological support is provided in their respective processes
• Communicate study plans, project timelines, budget projections, progress reports, interim and final study results to internal Jazz teams on time
• Present research findings at scientific congresses and co-author manuscripts for publication in peer-reviewed journals.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines

Required Knowledge, Skills, and Abilities

• Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences)
• At least 2 years of experience in the pharmaceutical industry, CRO or in academia
• Experience with rare disease studies
• Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study
• Experience successfully coordinating cross-functional processes
• Experience analyzing secondary data sources (administrative claims and EMR databases)
• Excellent oral and written communication skills in English
• Solid understanding of epidemiology and biostatistics
• Experience managing multiple projects and reprioritizing work when necessary
• Capable of working remotely with minimal supervision
• Proficiency with MS Word, Excel and PowerPoint
• Ability to travel approximately 10% time

Required/Preferred Education and Licenses

• Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform
• Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)
• Experience conducting post-marketing safety studies of marketed medicines
• Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company
• Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities
• Data analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology

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